Inke S.A: APIs manufacturing plant.
01 1Inke S.A
02 1Coral Drugs Private Limited
03 1Axplora
04 1Fermion Oy
05 1TAPI Technology & API Services
06 1Amphastar Pharmaceuticals
07 1Astellas Pharma
08 1Cipla
09 2Industriale Chimica
10 1Lusochimica
11 1MSN Laboratories
12 1Sicor Societa Italiana Corticosteroidi Srl
13 1Viatris
14 1Blank
01 5FORMOTEROL FUMARATE
02 3FORMOTEROL FUMARATE DIHYDRATE
03 1FORMOTEROL FUMARATE DIHYDRATE MICRONIZED
04 2FORMOTEROL FUMARATE DIHYDRATE USP
05 2FORMOTEROL FUMARATE USP
06 1FORMOTEROL FUMARATE USP [ROUTE CODE "FL"]
07 1FORMOTEROL FUMERATE
01 1Finland
02 1Germany
03 3India
04 1Israel
05 4Italy
06 1Japan
07 1Spain
08 2U.S.A
09 1Blank
01 11Active
02 4Inactive
01 7Complete
02 8Blank
GDUFA
DMF Review : Complete
Rev. Date : 2017-06-16
Pay. Date : 2017-05-10
DMF Number : 16628
Submission : 2003-06-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30324
Submission : 2016-06-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32936
Submission : 2018-07-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-09-19
Pay. Date : 2019-06-25
DMF Number : 33894
Submission : 2019-07-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-26
Pay. Date : 2012-12-03
DMF Number : 21357
Submission : 2008-02-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-05-17
Pay. Date : 2018-03-19
DMF Number : 20178
Submission : 2007-04-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-09-14
Pay. Date : 2017-06-20
DMF Number : 20199
Submission : 2007-01-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-02
Pay. Date : 2013-01-22
DMF Number : 23848
Submission : 2010-05-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-10-24
Pay. Date : 2018-07-26
DMF Number : 28011
Submission : 2014-03-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19202
Submission : 2006-02-21
Status : Active
Type : II
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